What Is the FDA and Why Do They Inspect Clinical Research Sites?
The FDA (Food and Drug Administration) is the U.S. government agency that ensures medical products are safe, effective, and properly tested before they reach the public. One of the ways the FDA ensures this is by conducting inspections at clinical research sites like Biotrial.
These inspections are thorough and detailed. The FDA examines:
- How we protect the rights and safety of study participants
- How accurately we collect and store study data
- Whether we follow all laws and research regulations
- How we train our staff and follow study protocols
Inspections are often unannounced and very rigorous—and that is exactly how it should be. They help ensure that every clinical trial meets the highest standards.
What Is a Form 483?
When the FDA finds a problem during an inspection, they document it using a form called a Form 483. This could range from minor paperwork issues to more serious concerns about how a study is being conducted.
Sites that receive a Form 483 are required to fix the issues and explain how they will do better in the future.
At Biotrial, we are proud to report that the FDA issued no Form 483 during their recent inspection. That means they found no problems or deficiencies at all.
Why This Matters to You as a Volunteer or Patient?
Choosing to take part in a clinical trial is a big decision. You want to know that you are in good hands. This inspection result is a clear sign that:
- Our studies are safe, professional, and well-managed
- Your data and health information are protected and handled with care
- You will be treated with respect, compassion, and transparency
In fact, the FDA specifically praised Biotrial for our transparency, data integrity, and operational excellence—a reflection of our entire team’s dedication and high standards.
A Word of Thanks
This achievement would not be possible without the dedication of our amazing staff and the trust of our volunteers and patients. You are the heart of what we do. Your participation helps bring new treatments and medical breakthroughs to the world—and we are honored to support you at every step.
Interested in Joining a Clinical Trial?
We always seek volunteers— healthy individuals and patients—who want to make a difference in medical research.
- Visit our Volunteer Page to explore open studies and sign up.
- Have questions? Reach out to our friendly team—we are happy to help.
Join a clinical trial and help advance medical research while earning compensation for your participation. It’s easy, secure, and your contribution could make a real difference.
